Virtual Reality Outperforms Game Card Distraction in Reducing Distress During Pediatric Wound Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-05-30

Brief Summary

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Children often experience fear, anxiety, and pain during wound care procedures, which can make treatment more difficult and distressing. Non-pharmacological distraction techniques may help reduce these negative experiences without the use of medications. Virtual reality (VR) provides immersive visual and auditory stimulation, while simple distraction tools such as game cards offer a low-cost alternative.

This randomized controlled study aims to compare the effectiveness of immersive virtual reality glasses and distraction game cards in reducing fear, anxiety, pain, and physiological stress responses in children aged 5 to 10 years undergoing open wound care. Ninety children are randomly assigned to one of three groups: standard care alone, standard care with distraction game cards, or standard care with virtual reality glasses. Psychological outcomes (fear, anxiety, and pain) and physiological indicators (heart rate and oxygen saturation) are measured before and after the wound care procedure. The results of this study will help identify effective, non-pharmacological strategies to improve children's experiences during painful medical procedures and support child-centered care in pediatric clinical settings.

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Detailed Description

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Open wound care procedures are common in pediatric emergency settings and are frequently associated with fear, anxiety, pain, and physiological stress in children. These responses may interfere with cooperation during treatment and negatively affect children's short- and long-term perceptions of healthcare. Although pharmacological approaches can reduce pain, non-pharmacological interventions are increasingly recommended as complementary strategies to minimize distress without additional medical risk.

Distraction techniques represent one of the most widely used non-pharmacological approaches in pediatric care. Immersive virtual reality (VR) has gained attention as a promising distraction method due to its ability to provide multisensory engagement and strong attentional capture. By immersing children in an interactive virtual environment, VR may reduce awareness of painful stimuli and procedural threat. In contrast, distraction game cards offer a simple, low-cost alternative that engages children cognitively through visual search and pattern recognition tasks. Despite growing evidence supporting both approaches, direct comparisons between immersive VR and low-cost distraction methods during pediatric wound care remain limited.

This study is designed as a single-center, parallel-group randomized controlled trial conducted in the pediatric emergency department of Agri Training and Research Hospital in Turkey. Children aged 5-10 years who require open wound care, including cleansing, dressing, or suturing, are eligible to participate. Following informed consent from parents or guardians and assent from children, participants are randomly allocated in a 1:1:1 ratio to one of three groups: standard wound care alone (control group), standard care with distraction game cards, or standard care with immersive virtual reality glasses.

All participants receive wound care according to institutional clinical protocols. Children in the virtual reality group wear VR glasses displaying age-appropriate immersive content throughout the procedure. Children in the game card group engage with illustrated distraction cards facilitated by a trained researcher. Psychological outcomes, including fear, state anxiety, and pain, are assessed immediately before and shortly after the procedure using validated child-appropriate scales. Physiological responses, including heart rate and peripheral oxygen saturation, are measured concurrently using a pulse oximeter.

The primary objective of the study is to compare post-procedural fear, anxiety, and pain levels between groups. Secondary objectives include evaluation of within-group changes and comparison of physiological stress indicators across interventions. By directly comparing immersive virtual reality with a simple, low-cost distraction method, this study aims to provide clinically relevant evidence to inform the selection of effective, feasible, and scalable non-pharmacological interventions for pediatric wound care.

Conditions

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Pediatric Wounds Procedural Pain Procedure-Related Anxiety Procedural Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: standard care alone (control), standard care with distraction game cards, or standard care with immersive virtual reality glasses.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Due to the nature of the distraction interventions, participants and care providers were not blinded. Outcome assessment and data entry were performed by a research assistant who was blinded to group allocation.

Study Groups

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Standard Care Control Group

Participants received standard pediatric wound care according to institutional protocols, including wound cleansing, debridement, suturing when clinically indicated, and dressing application, without any structured distraction intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Distraction Game Card Group

Participants received standard wound care combined with distraction using illustrated game cards. Children engaged in visual search and pattern recognition activities facilitated by a trained researcher throughout the wound care procedure.

Group Type EXPERIMENTAL

Distraction Game Cards

Intervention Type BEHAVIORAL

Laminated illustrated game cards containing visual search and pattern-recognition tasks were used as a behavioral distraction during pediatric wound care. A trained researcher facilitated engagement by asking structured questions approximately every 15-30 seconds throughout the procedure to maintain the child's attention.

Virtual Reality Distraction Group

Participants received standard wound care combined with immersive virtual reality distraction delivered through virtual reality glasses displaying age-appropriate three-dimensional and 360-degree content during the procedure.

Group Type EXPERIMENTAL

Virtual Reality Distraction

Intervention Type BEHAVIORAL

Immersive virtual reality distraction was delivered using virtual reality glasses connected to a smartphone displaying age-appropriate three-dimensional and 360-degree audiovisual content throughout the wound care procedure to provide multisensory engagement and reduce procedural distress.

Interventions

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Distraction Game Cards

Laminated illustrated game cards containing visual search and pattern-recognition tasks were used as a behavioral distraction during pediatric wound care. A trained researcher facilitated engagement by asking structured questions approximately every 15-30 seconds throughout the procedure to maintain the child's attention.

Intervention Type BEHAVIORAL

Virtual Reality Distraction

Immersive virtual reality distraction was delivered using virtual reality glasses connected to a smartphone displaying age-appropriate three-dimensional and 360-degree audiovisual content throughout the wound care procedure to provide multisensory engagement and reduce procedural distress.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Presentation with an open wound requiring wound care procedures such as cleansing, dressing, debridement, and/or suturing.

Hemodynamic stability at baseline (peripheral oxygen saturation ≥95% and heart rate within age-appropriate limits).

Ability to communicate sufficiently to complete study assessments.

Provision of written informed consent by a parent or legal guardian.

Provision of verbal assent by the child. -

Exclusion Criteria

Significant visual or hearing impairment.

Head or facial wounds that prevent the use of virtual reality glasses.

History of motion sickness or previous adverse reactions to virtual reality.

Receipt of sedatives or systemic opioid analgesics within 6 hours prior to the procedure.

Requirement for procedural sedation during wound care.

Any clinical condition deemed by the attending physician to make participation inappropriate.

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Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes